Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
Summary
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.
Description
Approximately 20% of pregnant women require medical intervention to induce labour for reasons including post-date pregnancy, pre-eclampsia, maternal diabetes, premature rupture of the membranes and intra-uterine fetal growth retardation. There are two fundamental changes that characterise pre-labour preparation for delivery: sensitisation of the myometrium to produce contractions, and ripening (softening and dilation) of the cervix. Prostaglandins (PG) are fundamental to both of these changes, and several forms have been used to successfully induce labour. Dinoprostone (PGE2) is an example of a cervical ripening agent that is available in gel and tablet form and has a proven record of successful cervical ripening in this population. Dinoprostone is also available in a controlled release vaginal delivery system, which is manufactured by Controlled Therapeutics (Scotland) a subsidiary of Cytokine PharmaSciences, Inc., King of Prussia, PA, USA.
Another synthetic prostaglandin that has been shown to be an effective cervical ripener and labour inducer is misoprostol. Oral tablets are broken into fragments and used intravaginally to ripen the cervix and induce labour Due to the disadvantages of existing cervical ripeners (delivery of bolus doses, freezer or refrigerated storage, lack of efficacy in labour induction), and due to safety concerns with the off-label use of oral misoprostol tablet fragments, Controlled Therapeutics has developed a controlled release vaginal delivery system similar to its marketed dinoprostone product but containing misoprostol.
This study examines four dose strengths of the misoprostol vaginal insert in women who need to have their labours induced.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Labor Induction
Intervention
Misoprostol vaginal insert 25 mcg, Misoprostol vaginal insert 50 mcg, Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 200 mcg
Location
Birmingham Women's Hospital
Birmingham
United Kingdom
B13 9HP
Status
Completed
Source
Cytokine PharmaSciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00346840
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vaginal Smears
Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.
Episiotomy
An incision of the posterior vaginal wall and a portion of the pudenda which enlarges the vaginal introitus to facilitate delivery and prevent lacerations.
Misoprostol
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
Vaginal Neoplasms
Tumors or cancer of the VAGINA.
Vaginal Diseases
Pathological processes of the VAGINA.
Clinical Trials
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in...
Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and i...
Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vagina...
Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy
The hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group...
The purpose of this study is to determine the effectiveness of buccal misoprostol and comparing this with vaginal route of the same drug.
PubMed Articles
OBJECTIVE: We compared the safety and effectiveness of oxytocin, dinoprostone and misoprostol for cervical priming. STUDY DESIGN: A total of 218 patients were enrolled to receive between one and three...
Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients.
OBJECTIVE: To evaluate and compare the effectiveness of oral and vaginal misoprostol versus placebo to facilitate office hysteroscopy without anesthesia during infertile diagnostic evaluation. DESIGN:...
PURPOSE: Absorption and effectiveness of vaginally administered misoprostol tablets may vary according to the medium in which it is placed. This study was directed to compare the outcomes of vaginal a...
Aim: To compare immediate induction with vaginal misoprostol tablets and immediate induction with vaginal dinoprostone (naturally occurring prostaglandin E(2) [PGE(2) ]) gel in women with premature...
OBJECTIVES: To evaluate the efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone in medical abortion of ≤56 days....
